Orange Book Listing Creates Injury To Support Standing To Appeal IPR Decision

Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and Appeal Board (PTAB) in a IPR proceeding. In Amerigen Pharmaceuticals v. UCB Pharma GMBH, the Federal Circuit held that a would-be generic competitor whose ANDA was tentatively approved but subject to a Paragraph III certification against the challenged patent had standing to appeal the PTAB decision upholding the patent. While Amerigen prevailed on that issue, the court affirmed the PTAB decision on the merits.

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USPTO Issues Revised Patent Subject Matter Eligibility Guidance

Although the Department of Commerce is impacted by the partial Federal government shutdown, the USPTO has been able to continue normal operations because it has access to prior-year fee collections. Underscoring its active status, the USPTO released revised patent subject matter eligibility guidance, effective January 7, 2019. This guidance implements the changes Director Iancu announced in his keynote address at the Intellectual Property Owners Association Annual Meeting, and may lead examiners to determine that more inventions satisfy § 101 at an early stage of a Mayo/Alice analysis. The guidance is effective immediately, but the USPTO will accept written comments through March 8, 2019.

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USPTO Terminates Extended Missing Parts Pilot Program

The USPTO has announced that it will not be extending the Extended Missing Parts Pilot program, so it will end on January 2, 2019. While many USPTO pilot programs are renewed time after time–the Pre-Appeal Brief Review pilot program was launched in 2005–the willingness to terminate less successful pilot programs gives the USPTO flexibility to test different initiatives designed to advance and support the examination process.

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Federal Circuit Says No OTDP Between Novartis Patents That Straddle URAA

In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an OTDP reference against a pre-URAA parent patent having the same priority date, and upheld the validity of an Orange Book-listed patent for Novartis’s Zortress® and Afinitor® products. This decision was issued the same day the Federal Circuit held that a patent term extension award does not itself raise OTDP issues, upholding the validity of Novartis’s Galenya® product patent.

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Federal Circuit Protects Novartis Gilenya Patent From Obviousness-Type Double Patenting

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical patent owners will welcome this decision as reinforcing the validity of patents during their PTE term, and may consider how it might apply to similar circumstances raised by a patent term adjustment (PTA) award.

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